Kyowa Hakko Kirin Co. Ltd. said FDA has granted approval for Poteligeo (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. FDA granted Priority Review and Breakthrough Therapy Designation in late 2017.
Poteligeo is a humanized monoclonal antibody directed against CC chemokine receptor 4, which is frequently expressed on leukemic cells of certain blood cancers including CTCL. Using the proprietary Potelligent technology, the amount of fucose in the sugar chain structure of Poteligeo is reduced, which enhances the antibody dependent cellular cytotoxicity.
“Mycosis fungoides and Sézary syndrome can be disfiguring, and debilitating. MAVORIC, the largest study of systemic therapy ever conducted in MF and SS, showed that mogamulizumab prolonged progression-free survival compared to vorinostat in patients with relapsed or refractory MF or SS,” said Jeffrey Humphrey, president of Kyowa Kirin Pharmaceutical Development, Inc. “We look forward to the publication of MAVORIC’s primary results and to ongoing scientific exchange within the medical and academic communities.”
Because CTCL manifests itself in skin lesions, it is often mistaken for other non-critical skin conditions, which can delay conclusive diagnosis and treatment options. MF and SS are the two most common subtypes of CTCL. MF is the most common subtype, accounting for 50-70% of cases. It is a slow progressing form of lymphoma that can involve the skin, blood, lymph nodes and organs, and may be associated with severe infections. SS accounts for approximately 3% of CTCL cases and is a more aggressive, leukemic form of CTCL.
FDA approval of Poteligeo is supported by the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus Comparator In CTCL) study, which is the largest randomized trial in MF and SS and the first pivotal trial in CTCL to use PFS as a primary endpoint.
MAVORIC was a phase III open-label, multi-center, randomized study of mogamulizumab versus vorinostat in patients with MF and SS who have failed at least one prior systemic treatment. The study was conducted in the U.S., Europe, Japan and Australia, and randomized a total of 372 patients to mogamulizumab or vorinostat. The results showed that mogamulizumab demonstrated significantly superior PFS at a median of 7.6 months [95% CI: 5.6, 10.2] compared to 3.1 months with vorinostat [95% CI: 2.8, 4.0], [hazard ratio 0.53: 95% CI: 0.41, 0.69; p<0.001]. The confirmed overall response rate for mogamulizumab and vorinostat was 28% and 5%, respectively (p<0.001).
FDA granted Poteligeo Breakthrough Therapy Designation for the treatment of MF and SS in adult patients, and evaluated Poteligeo with Priority Review, which is reserved for drugs that treat a serious condition and, if approved, would provide a significant improvement in treatment safety or effectiveness.
